Handheld, battery powered, biomicroscope that projects light into a patient’s eye. It is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the…
Handheld, battery powered, biomicroscope that projects light into a patient’s eye. It is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
Who Else Makes It
Concentrated in Jiangsu (3), Chongqing (2), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for PSL Portable Slit Lamp | Listed by | Reichert Inc., United States |
| FDA product code | HJO |
| Device type | Biomicroscope, Slit-Lamp, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1850 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K061330 |
| Record published | 2016-09-22 |
| Record revised | 2022-12-20 (version 5) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.